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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K172057
Device Name Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
Applicant
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick,  IE
Applicant Contact Orla Gunning
Correspondent
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick,  IE
Correspondent Contact Orla Gunning
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/06/2017
Decision Date 03/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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